Orsiro Mission 2.25/9/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07640130455818), received between Jul 10, 2023 and Jun 3, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 3, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN UNSPECIFIED LESION IN A SEGMENT OF THE DISTAL LAD. A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25373561 ↗
• MalfunctionMay 5, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE MEDIAL LCX. A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25080471 ↗
• MalfunctionApr 10, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A SEGMENT OF THE PROXIMAL TO MEDIAL BIFURCATION TO THE D1. IT IS UNKNOWN IF A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24838226 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A MODERATELY CALCIFIED LESION (95 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE OSTIAL OM1. A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615216 ↗
• MalfunctionMar 17, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A SEGMENT OF THE PROXIMAL LCX. A PRE-DILATION OF THE LESION WAS NOT PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615215 ↗
• MalfunctionFeb 27, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN AN UNKNOWN TARGET VESSEL. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24469263 ↗
• MalfunctionFeb 4, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (99 % STENOSIS DEGREE) IN A MILDLY TORTUOUS SEGMENT OF THE DISTAL RCA. A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THE COMPLAINT DEVICE WAS NOT RETURNED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256791 ↗
• MalfunctionFeb 3, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 % STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE DISTAL RCA. AFTER PRE-DILATION OF THE LESION WITH A 2.0 X 15 MM BALLOON, THE AFFECTED ORSIRO MISSION WAS INTRODUCED INTO THE PATIENT'S BODY BUT WAS UNABLE TO CROSS THE LESION. EVENTUALLY, AN 2.0 X 12 MM STENT WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243122 ↗
• MalfunctionNov 28, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY TO SEVERELY CALCIFIED LESION (90% STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE MID TO DISTAL LAD. IT WAS REPORTED THAT THE STENT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669704 ↗
• MalfunctionJul 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT EMBOLIZED IN A SEVERELY CALCIFIED AND TORTUOUS DISTAL LCX. THE PATIENT WAS FLAILING THROUGHOUT THE CASE, WHICH COMPLICATED MATTERS AS WELL. IT IS BELIEVED THAT THE DOCTOR WAS ABLE TO BALLOON EMBOLIZE THE STENT INTO THE VESSEL WALL, BUT IT COULD NOT BE CONFIRMED BASED ON LIMITED STENT VISIBILITY. STENT CATHETER WAS DISPOSED IN THE HEAT OF A DIFFICULT CASE, SO IT IS NOT AVAILABLE FOR INSPECTION. AFTER ADDITIONAL CORRESPONDENCE WITH THE LOCAL STAFF, IT WAS CLARIFIED THAT THERE WERE THREE 90 PERCENT LESIONS WHICH HAD ALREADY BEEN BALLOONED AND STENTED, EXCEPT FOR THE DISTAL SEGMENT. WHEN TRYING TO DELIVER THE SMALLEST/SHORTEST STENT TO THE DISTAL LOCATION, THE SYSTEM WAS STUCK INSIDE THE PROXIMAL STENTS AND THEN DISLODGED DURING THE RETRIEVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817697 ↗
• MalfunctionJul 10, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PREDILATED LESION IN A MILDLY TORTUOUS MID-SECTION OF THE CX. AFTER UNSUCCESSFUL ATTEMPT TO CROSS THE LESION, THE DEVICE WAS WITHDRAWN INTO THE GUIDE, AND DURING REMOVAL THE STENT WAS STRIPPED OFF IN THE CO-PILOT. THE STENT WAS REMOVED FROM THE CO-PILOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17291650 ↗